Kornimate/medical-research-clean huggingface dataset:
mahana tinnitus pilot

Conditions: Tinnitus

Summary: the main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of mahana™ tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.

following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. eligible participants will be enrolled, and will receive access to mhna-003 (mahana™ tinnitus). participants will use mhna-003 for 6 weeks, completing assessments at baseline and weeks 2, 4, and 6 following baseline.

Eligibility criteria:
inclusion criteria: * participant scores ≥ 25 on the tinnitus functional index. * participant has experienced symptoms of tinnitus for at least 3 months. * participant is at least 18 years of age at the time of consent. * participant resides in the united states. * participant is able to speak, read, and understand english. * participant has access to an ios or android smartphone with the ability to complete study tasks. * participant is able to commit the time required to complete therapy modules and study assessments. exclusion criteria: * participant scores ≥2 on item 9 (suicidal thoughts) of the beck's depression index (bdi). * participant has been hospitalized for psychiatric reasons within 12 months of screening. * participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.
italian data registry of patients undergoing peripheral nerve block performed in the emergency departments

Conditions: Emergency; Point of Care Ultrasound (POCUS); Anesthesia; Acute Pain; Trauma

Summary: this data registry aim is to describe the practice of point-of-care ultrasound guided regional anaesthesia (pocus-gra) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (pnb) in common clinical practice for the treatment of acute pain due to bone fractures.

pain in emergency departments (eds) is often inadequately treated. the consequences of inadequate treatment of pain defined as "oligoanalgesia," can have a negative impact on patient outcomes. the main reasons for this include lack of appropriate pathways, incorrect habits and aversion to opioid use. pain is a symptom present in 78% of patients entering emergency departments, and among the main causes is trauma. a multimodal approach to pain treatment is more effective and minimizes side effects such as nausea, vomiting, and drowsiness due to the use of some drugs such as opioids. over the past fifteen years, numerous studies have demonstrated the effectiveness of pain treatment using point-of-care ultrasound guided regional anaesthesia (pocus-gra) even outside the operating room. this data registry aim is to describe the practice of point-of-care ultrasound guided regional anaesthesia (pocus-gra) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (pnb) in common clinical practice for the treatment of acute pain due to bone fractures.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * nrs\>3 * patients with traumatic fractures of ≤2 districts (radiologically confirmed (rx or ct). districts are: chest (one hemilateral) pelvis (one hemilateral) femur leg ankle foot shoulder humerus forearm hand/fingers - presence of written informed consent to the study. exclusion criteria: * intubated patients * patients with known dementia * patients with delirium (assessed by confusion assessment method) * pregnant patients * patients with allergies to local anesthetics * patients unable to adequately communicate pain
a comparative study of aleglitazar and actos in patients with type 2 diabetes mellitus and new york heart association (nyha) class ii heart failure.

Conditions: Diabetes Mellitus Type 2

Summary: this 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and actos in patients with type 2 diabetes and symptomatic nyha class ii heart failure. eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * type 2 diabetes for \>=1 month; * drug naive, or receiving stable doses of \<=2 oral antihyperglycemic medications; * hba1c 6.5-10.0% at screening; * symptomatic, stable nyha class 2 heart failure at screening. exclusion criteria: * type 1 diabetes; * current or previous treatment with insulin; * uncontrolled hypertension; * nyha class 1, 3 or 4 at screening.
glp-1 and hypoglycemia

Conditions: Type 2 Diabetes Mellitus

Summary: low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. the purpose of this study is to learn if and how glucagon-like peptide-1 (glp-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.


Eligibility criteria:
inclusion criteria: * 14 (7 males, 7 females) healthy controls age 30-60 yr. * 14 (7 males, 7 females) people with type 2 dm age 30-60 yr. * for type 2 dm: hba1c 6-10.0% * no significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.) * body mass index \>25kg • m-2 exclusion criteria: -

Keywords: hypoglycemia glp-1 type 2 diabetes endothelial function
the role of dopaminergic and glutamatergic neurotransmission for dysfunctional learning in alcohol use disorders

Conditions: Alcohol Use Disorder

Summary: the aim of this project is to assess reward- based learning behavior and its association with alterations in dopaminergic and glutamatergic transmission in detoxified alcohol-dependent patients and matched controls. the investigators will explore how these alterations interact with clinical and psychosocial factors which can modify the relapse risk and learning deficits. patients will be detoxified in an inpatient setting. clinical assessments, behavioral paradigms of learning and brain imaging will be carried out within at least 4 half- lives after any psychotropic medication. the investigators will implement and apply functional imaging paradigms assessing pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters of learning with alcohol craving, intake and prospective relapse risk. in this project, the impact of the dopamine x glutamate interaction on learning deficits and consecutive relapse probability is targeted with \[18f\]fallypride pet and the measurement of absolute concentrations of glutamate with magnetic resonance spectroscopy (mrs).

alcohol consumption despite negative consequences may rely on impaired flexibility in adapting the behavior to environmental changes, i.e. learning in response to reward contingencies. this learning deficit is of clinical relevance particularly during therapy and for the psychosocial outcome. the reduced availability of central dopamine d2-receptors in detoxified alcohol dependent patients observed in pet investigations and their hypothetical effects on reward-related learning are in line with evidence for learning deficits in hypodopaminergic states, particularly for avoidance learning in non-dependent samples. growing evidence indicates that the learning-related striatal dopamine signals are modulated by higher executive functions involving, e.g., the prefrontal cortex. here, broad glutamatergic outputs of the prefrontal cortex are crucial for subcortical learning mechanisms and match with recent models of interactive dopamine-glutamate dysfunctions and models of neurotrophic signaling in alcohol dependence.

Eligibility criteria:
inclusion criteria: * alcohol dependence according to dsm-iv * minimum of 72 hours of abstinence, maximum of 21 days of abstinence * minimum of three years of alcohol dependence * low severity of withdrawal symptoms * ability to provide fully informed consent and to use self- rating scales exclusion criteria: * lifetime history of dsm- iv bipolar or psychotic disorder * current threshold dsm-iv diagnosis of any following disorders: current major - depressive disorder, generalized anxiety disorder, ptsd, borderline personality disorder or obsessive- compulsive disorder * history of substance dependence other than alcohol or nicotine dependence

Keywords: reward- based learning pavlovian-to-instrumental transfer relapse risk positron emission tomography (pet) magnetic resonance spectroscopy (mrs) dopamine receptor availability glutamate
high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors

Conditions: Central Nervous System Neoplasm

Summary: this pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. it may also help doctors understand how well patients respond to treatment.

primary objectives: i. to estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors. secondary objectives: i. to assess the geometric mean titer (gmt) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (gmt) among 38 patients receiving the standard yearly influenza vaccination. ii. to assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza vaccination. iii. to assess the seroprotection rates (i.e. post-vaccination titer \>= 1:40) compared to previously determined seroconversion and seroprotection following administration of the standard yearly influenza vaccination. tertiary objectives: i. to assess the relationship between serologic markers of immune function and response to high-dose vaccination. outline: patients receive trivalent influenza vaccine on day 1. after completion of study, patients are followed up at 28 days and/or 3 months.

Eligibility criteria:
inclusion criteria: * patients must have a clinical diagnosis of a primary central nervous system tumor * patients must be eligible to receive the influenza vaccine * patients must be willing to receive the fluzone® high-dose seasonal influenza vaccine * patients must be willing and able to sign an institutional review board (irb)-approved written informed consent document exclusion criteria: * patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, guillain-barré syndrome, or other contraindication to the vaccine * patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study
study of corneas undergoing balanced salt solution(bss ®) versus glucose-bicarbonate-ringer lactate in cataract surgery

Conditions: Cataract

Summary: this is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (bss ® versus glucose-bicarbonate-ringer lactate - gbrl) on the health of the cornea after cataract surgery by phacoemulsification.


Eligibility criteria:
inclusion criteria: * uncomplicated senile cataract * visual acuity (va) between 20/40 and 20/400 * healthy corneas exclusion criteria: * mental incapacity * patients with coexisting diseases of the cornea * presence of corneal opacity * uncontrolled glaucoma * uncontrolled diabetes mellitus * uveitis * cells or flare in the anterior chamber * prior intraocular surgery * patients using topical steroids or systemic * traumatic cataract, hereditary or toxic

Keywords: corneal endothelium cataract surgery irrigation solutions intraocular phacoemulsification
comparison of concussion education programs

Conditions: Concussion, Brain

Summary: importance: concussion underreporting leads to delays in diagnosis and treatment, resulting in prolonged recovery. athletes' report of concussion symptoms is therefore an important component of risk reduction. numerous educational interventions to improve concussion knowledge and reporting exist. objective: evaluate the comparative efficacy of three concussion education programs in improving concussion-reporting intention. design: randomized clinical trial conducted from august 2018 to october 2018, with assessment before, immediately after, and one-month after educational intervention.


Eligibility criteria:
inclusion: * athletes from three high school football teams in california. * in attendance for practice on both study dates * provided signed assent and parental consent. exclusion: * did not complete more than 50% of the questionnaire.
safety and efficacy of hectorol in pediatric patients with chronic kidney disease stage 3 and 4 with secondary hyperparathyroidism not yet on dialysis

Conditions: Secondary Hyperparathyroidism-Chronic Kidney Disease

Summary: primary objective: evaluate the effect of hectorol® capsules in reducing elevated levels of intact parathyroid hormone (ipth). secondary objectives: * evaluate the safety profile of hectorol® capsules versus rocaltrol® (calcitriol) capsules. * determine the pharmacokinetic profile of 1,25-dihydroxyvitamin d2 after administration of hectorol®.

the total study duration per patient will be approximately up to 28 weeks.

Eligibility criteria:
inclusion criteria : * male or female aged 5 to 18 years old. * weight ≥15 kg. * chronic kidney disease (ckd) stage 3 or 4 not on dialysis, defined as glomerular filtration rate (gfr) between 15 and 59 ml/min/1.73m\^2 (established by schwartz equation) at week -2 visit. * intact parathyroid hormone (ipth) value \>100 pg/ml for ckd stage 3 or \>160 pg/ml for ckd stage 4, at week -2 visit. * signed informed consent/assent form. exclusion criteria: * the patient has a serum 25-hydroxyvitamin d level \<30 ng/ml at screening. * the patient has a corrected calcium ≥10 mg/dl at the week -2 visit. * the patient has a serum phosphorus \>4.5 mg/dl for children 13 to 18 years of age; \>5.8 mg/dl for children 5 to 12 years of age at the week -2 visit. * the patient is anticipated to require maintenance hemodialysis within 3 months. * the patient used cinacalcet or vitamin d sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit. * the patient has a history of, or active, symptomatic heart disease within 12 months prior to the baseline (week 0) visit. * the patient currently has a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy). * the patient currently has primary hyperparathyroidism or has had a total parathyroidectomy. * the patient has an active malignancy. * the patient is unable to swallow a capsule in size similar to the hectorol® and rocaltrol® capsules. * the patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin d analogs. * the patient currently uses aluminum or magnesium-based binders. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
covid-19 in home healthcare

Conditions: Covid19

Summary: assessment of cause of death in home healthcare residents in östergötland county, sweden, who had a positive covid-19 diagnosis and died between march and september 2020. our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive covid-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of covid-19 to those fatal outcomes.


Eligibility criteria:
inclusion criteria: * adult (\< 18 years) individuals and * cared for in home healthcare in östergötland county and * positive covid-19 diagnosis and * diseased between march and september 2020 exclusion criteria: * none
baltimore hears: hearing health equity through accessible research & solutions

Conditions: Age-related Hearing Impairment 1; Personal Communication

Summary: age-related hearing loss is highly prevalent and hearing health care is underutilized. the primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (chw)-delivered hearing loss intervention program. a preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. the proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in baltimore. primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. this trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.


Eligibility criteria:
inclusion criteria: * age 60 years or older * english-speaking * aural-oral verbal communication as primary communication modality * post-lingual hearing loss (audiometric pure tone averages \[0.5-4khz\] in both ears \>25 db) * does not currently use a hearing amplification device or hearing aid * signed informed consent to participate in all study related activities * willing to regularly use listening device once provided for the remainder of their time in the study * hearing handicap as measured by hhie-s score \>8 * able to follow study instructions exclusion criteria: * individuals who do not fulfill inclusion criteria * evidence of ear disease or pathology requiring further medical evaluation
study of the genome, gut metagenome and diet of patients with incident parkinson's disease

Conditions: Parkinson Disease; Genetic Predisposition

Summary: a case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident parkinson's disease.

two groups of subjects - one including healthy individuals and the other - treatment-naive patients with incident parkinson's disease - will fill in the food frequency questionnaire, sf-36 questionnaire, hads questionnaire and the physical activity questionnaire. all subjects must have 0-3 points on hoehn and yahr scale and more than 22 points on moca scale. dna microarray genotyping will be used to process the dna samples of the participants. the data on the composition of the participants' gut microbiota will be obtained through 16s rrna sequencing of their stool samples.

Eligibility criteria:
inclusion criteria: * men and women aged 45 years and over who have been diagnosed with parkinson's disease * subject signed informed consent exclusion criteria: * gastroenterological diseases such as ulcerative colitis, crohn's disease, celiac disease, gallbladder diseases (calculous cholecystitis, cholangitis, etc.) that are not related to functional disorders, a liver diseases or pancreas in medical history * exacerbations of chronic gastroenterological diseases * mental illness * oncology diseases * mental disorders * rheumatoid arthritis or other autoimmune diseases * acute infectious diseases or exacerbation of any diseases * recent (\<3 months) administration of proton pump inhibitors, antimicrobial therapy or surgical intervention * recent (\<3 weeks) use of probiotics, antacids, nonsteroidal anti-inflammatory drugs, laxatives * recent (\<14 days) administration of laxatives (excluding prucaloprid) * recent (\< 3 months) surgical intervention * pregnancy, planning to be pregnant or breast feeding at any point during the study or study enrollment * current alcohol/drug abuse (more than 3 points for women and 4 for men according to audit-c questionnaire and/or more than 7 points on the audit questionnaire) or addiction therapy within 12 months prior to screening * planned relocation from the home region during the study * stroke in medical history * any surgical intervention in the central nervous system * morbid obesity, bmi\> 35 kg / m2 * a medical history of carriage or disease associated with a history of human immunodeficiency viruses, hepatitis b, c or treponema pallidum * the patient's inability to understand the essence of the study and agree to participate in it. moca scores \<22 * 4-5 stage of the disease according to the hen and yara scale * severe somatic pathologies or any factors that, in the opinion of the doctor, may prevent the patient from being included in the study * a medical history of serious head injuries * rheumatoid arthritis * tuberculosis

Keywords: gut microbiota parkinson's disease genetics microbiome ffq gpaq hads moca